1. Field of Invention
The present invention relates generally to medical apparatus and methods. More particularly, the present invention relates to systems, kits, and methods for removing endogenous fluids from or infusing therapeutic fluids to, retention sites in the body, such as the bladder, the pleural cavity, and the like.
Body fluids collect at different body sites for a variety of normal and abnormal reasons. For example, urine collects in the bladder as the result of normal body processes and, for most people at least, is removed from the bladder by periodic urination. In some individuals, urination may be difficult or impossible because of blockage of the urethra or other incapacities. In patients suffering from severe urinary incontinence, the urethra may be intentionally occluded in order to prevent uncontrolled urination but also preventing periodic urination needed to drain the bladder. Likewise, urine can accumulate in the upper urinary tract from ureteral obstructions requiring drainage. In all cases wherein the individual is unable to urinate at will, it may be necessary to provide interventional devices for permitting bladder drainage. Of particular interest to the present invention, such individuals are sometimes provided with transcutaneous catheters or shunts which permit drainage of the bladder to an external collection bag.
Another quite different condition which may require transcutaneous drainage results from the collection of effusate in the pleural cavity. Such pleural effusion can result from a variety of primary conditions, such as infection (empyema), cancer, asbestosis, congestive heart failure, and a number of other disorders. Chronic pleural effusion, particularly in cancer patients, can be treated by placement of a transcutaneous catheter having a collection end in the pleural cavity and a discharge end external to the patient.
The use of transcutaneous catheters for the drainage of the bladder, the pleural cavity, or other body sites is problematic in a number of respects. In particular, the presence of a transcutaneous catheter places the patient at great risk of infection because of the long-term percutaneous penetration that is maintained in the patient's skin. The presence of the external end of the catheter is difficult to maintain in a sterile condition, and it's physical presence is a great inconvenience to the patient.
Another condition which may require percutaneous drainage is the accumulation of ascites which result from liver, kidney, or heart disease or from obstruction of the inferior vena cava, hepatic vein, or portal vein. Ascites fluid accumulation can be considerable, causing discomfort or compromising breathing.
Another condition which can be treated with percutaneous drainage is hydrocephalus where cerebrospinal fluid (CSF) accumulates in the brain due to obstruction of flow or decreased reabsorption of CSF within the fluid filled structures of the central nervous system. Such accumulation increases ventricular pressure within and/or around the brain. Unless such excess CSF is removed, brain damage will occur.
Another condition that can be treated by percutaneous drainage is lymphodema which is an abnormal collection of lymph fluid within a tissue space or wound.
In addition to draining fluids, it is sometimes desirable to infuse fluids on a periodic or chronic basis to different body sites, often the same sites where fluids are being removed. For example, antibiotics can be administered to treat infections in the bladder, the pleural cavity, or other body cavities having transcutaneous catheters in place. Other therapeutic agents could also be administered, such as dissolving agents to treat stones in the bladder and kidney.
For these reasons, it would be desirable to provide alternative and improved apparatus, methods, and kits for providing drainage and/or infusion of retained fluids from body sites, such as the bladder, the pleural space, the liver, the kidney, the heart, the brain ventricles, the lymph spaces, and the like. Such apparatus, kits, and methods should reduce the risk of infection to the patient, be generally more tolerable to the patient than present drainage techniques, and preferably increase the safety and reliability of body fluid drainage. At least some of these objectives will be met by the invention described hereinafter.
2. Description of the Background Art
A transcutaneous tube for bladder drainage is described in U.S. Pat. No. 5,766,249. A transcutaneous system for draining the pleural cavity is described in U.S. Pat. No. 4,086,925. Transcutaneous catheters for peritoneal dialysis and other purposes are described in U.S. Pat. Nos. 5,215,530; 4,560,378; and 4,368,737. A percutaneous peritoneal dialysis system is described in U.S. Pat. No. 5,090,954. An internal shunt for draining pleural effusions to the peritoneal cavity is described in U.S. Pat. No. 4,850,955. An aspirator for draining the lungs of an infant is described in U.S. Pat. No. 4,921,488.
Implantable ports suitable for use in the systems of the present invention are described in U.S. patent application Ser. No. 08/942,990, filed on Oct. 2, 1997, and published PCT Application No. WO 98/31416, the full disclosures of which are incorporated herein by reference.